Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 116
- Locations
- 15
- Primary Endpoint
- 5-year event free survival rate
Study Overview
Brief Summary
Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for high risk acute lymphoblastic leukemia in children and adolescents.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •\ * Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following
- •1. 1 year old ≤ Age \< 10 years old
- •2. white blood cell at initial diagnosis \< 5x10\^10/L (50,000uL)
- •3. No testis involvement
- •4. Satisfaction of following organ functions
- •A. Kidney function (satisfies i or ii) i. Creatinine clearance (or radioisotope-measured GFR) ≥ 70mL/min/1.73m2 ii. Creatinine value according to age/sec satisfies the following:
- •1 to \< 2 years: Male: 0.6 / Female: 0.6, 2 to \< 6 years: Male: 0.8 / Female: 0.8, 6 to \< 10 years: Male: 1 / Female: 1, 10 to \< 13 years: Male: 1.2 / Female: 1.2, 13 to \< 16 years: Male: 1.5 / Female: 1.4, ≥ 16 years: Male: 1.7 / Female: 1.4 However, subjects who meet the selection criteria within 1 week before registration after receiving appropriate conservative treatment, including fluid therapy, can be registered.
- •B. Liver function i. Direct bilirubin \< 3.0mg/dL
Exclusion Criteria
- •Steroid administration within 2 weeks before the registration
- •t(9;22) or t(4;11)(q11;q23) or chromosome < 44 or iAMP21 or t(17;19)/TCF3-HLF
- •Newly diagnosed T cell ALL
- •One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome
- •Burkitt leukemia/lymphoma
- •In the presence of electrocardiographic findings suggesting uncontrolled cardiac dysfunction (e.g., unstable ischemia, symptomatic arrhythmia, congestive heart failure) or congenital long QT syndrome
- •When the clinical trial subject(or legal representative) does not consent or is unable to give written consent
Arms & Interventions
Standard-low (SL)
Induction-> SL Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance
Intervention: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate (Drug)
Standard-low (SL)
Induction-> SL Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance
Intervention: Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate (Drug)
Standard-low (SL)
Induction-> SL Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance
Intervention: Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate (Drug)
Standard-low (SL)
Induction-> SL Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance
Intervention: Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate (Drug)
Standard-low (SL)
Induction-> SL Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance
Intervention: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate (Drug)
Standard-average (SA)
Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance
Intervention: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate (Drug)
Standard-average (SA)
Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance
Intervention: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate (Drug)
Standard-average (SA)
Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance
Intervention: Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate (Drug)
Standard-average (SA)
Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance
Intervention: Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate (Drug)
Standard-average (SA)
Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance
Intervention: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate (Drug)
Standard-high 1 (SH1)
Induction-> SL Consolidation(4weeks)-> Intesified Consolidattion(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance
Intervention: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate (Drug)
Standard-high 1 (SH1)
Induction-> SL Consolidation(4weeks)-> Intesified Consolidattion(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance
Intervention: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate (Drug)
Standard-high 1 (SH1)
Induction-> SL Consolidation(4weeks)-> Intesified Consolidattion(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance
Intervention: Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate (Drug)
Standard-high 1 (SH1)
Induction-> SL Consolidation(4weeks)-> Intesified Consolidattion(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance
Intervention: Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate (Drug)
Standard-high 1 (SH1)
Induction-> SL Consolidation(4weeks)-> Intesified Consolidattion(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance
Intervention: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate (Drug)
Standard-high 2 (SH2)
Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance
Intervention: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate (Drug)
Standard-high 2 (SH2)
Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance
Intervention: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate (Drug)
Standard-high 2 (SH2)
Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance
Intervention: Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate (Drug)
Standard-high 2 (SH2)
Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance
Intervention: Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate (Drug)
Standard-high 2 (SH2)
Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance
Intervention: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate (Drug)
Outcomes
Primary Outcomes
5-year event free survival rate
Time Frame: Up to 5-years
Secondary Outcomes
- Confirmation of the therapeutic effect of the initial treatment response(Up to 5-years)
- Disease prognosis-related factor(Up to 5-years)
Investigators
Hee Young Ju
Clinical Professor
Samsung Medical Center